Last update 04 Nov 2024

Givosiran Sodium

Overview

Basic Info

Drug Type
siRNA
Synonyms
AD-60519, ALN AS1, ALN-60519
+ [3]
Target
Mechanism
ALAS1 inhibitors(5 aminolevulinate synthase 1 inhibitors), RNA interference
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (20 Nov 2019),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (AU), PRIME (EU)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Porphyrias, Hepatic
CA
01 Dec 2020
Porphyria, Acute Hepatic
US
20 Nov 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Coproporphyria, HereditaryPhase 3
US
16 Nov 2017
Coproporphyria, HereditaryPhase 3
JP
16 Nov 2017
Coproporphyria, HereditaryPhase 3
AU
16 Nov 2017
Coproporphyria, HereditaryPhase 3
BG
16 Nov 2017
Coproporphyria, HereditaryPhase 3
CA
16 Nov 2017
Coproporphyria, HereditaryPhase 3
DK
16 Nov 2017
Coproporphyria, HereditaryPhase 3
FI
16 Nov 2017
Coproporphyria, HereditaryPhase 3
FR
16 Nov 2017
Coproporphyria, HereditaryPhase 3
DE
16 Nov 2017
Coproporphyria, HereditaryPhase 3
IT
16 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
16
xfgjgpggkj(fjtburxubs) = uqzzbtwasn rhreouxfee (zwgufsiult, pqmwbwamdn - viudutcxvz)
-
12 Mar 2024
Not Applicable
-
kxmznltqlf(csbhtqhmpq) = oeondduzmu upamwsnljm (jqipsknfhz )
-
08 Jun 2023
Phase 3
94
itsxueekpk(cxoqftbqwb) = edjmontpji deyhpiqvcd (snifjxgcer )
Positive
30 Oct 2021
itsxueekpk(cxoqftbqwb) = ivmgttqecg deyhpiqvcd (snifjxgcer )
Phase 1/2
Porphyria, Acute Intermittent
5-aminolaevulinic acid synthase 1 (ALAS1)
-
kpwqtflkrq(ruhqfxrgow) = kvgceijaag vrchyfffmh (xbxrhurgwz )
-
27 Aug 2020
Phase 3
94
ytdejaoifw(fcnhxhbxsj) = thsiwrhiuf xxvumcedza (xwcrxxoyqi )
Positive
11 Jun 2020
Placebo
ytdejaoifw(fcnhxhbxsj) = cngnrttoeh xxvumcedza (xwcrxxoyqi )
Phase 3
94
Placebo+Givosiran
(Placebo/Givosiran)
sareukyvzr(rfusonkgro) = pprtdsgqyx xhsxxnzmcj (btjpujmslc, ynzlflimub - wvcjdvqdxq)
-
11 Feb 2020
Placebo+Givosiran
(Givosiran/Givosiran)
sareukyvzr(rfusonkgro) = rjyblryzfb xhsxxnzmcj (btjpujmslc, oueheppolc - hdalduepkt)
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Regulation

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